NCT06076057

Brief Summary

The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are:

  • Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.
  • Eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration. Participants will normal operating conditions, the researcher collects vital sign information.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 10, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

September 13, 2023

Last Update Submit

October 6, 2023

Conditions

Heart Rate Monitoring

Keywords

Vital SignsRespirationtranscutaneous oxygenationend-expiratory carbon dioxide

Outcome Measures

Primary Outcomes (8)

  • respiratory rate

    Breaths per minute

    3 month

  • heart rate

    beats per minute

    3 month

  • blood oxygen saturation

    Concentration of oxygen in the blood

    3 month

  • electromyography

    Measurement and analysis of electromyographic signals emitted during muscle contraction

    3 month

  • electroencephalogram

    Collecting brainwave signals，Analyze the EEG for abnormalities

    3 month

  • Partial pressure of end-expiratory CO2 concentration

    Measurement of the partial pressure of CO2 in exhaled gas at the end of expiration

    3 month

  • transcutaneous partial pressure of oxygen

    Measurement of the partial pressure of oxygen at the skin surface, thus indirectly reflecting the state of tissue oxygenation

    3 month

  • Percutaneous carbon dioxide partial pressure

    Indirectly reflecting the partial pressure of carbon dioxide by measuring the pH of the skin surface

    3 month

Study Arms (7)

8:00 Measurement team

At 08:00 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.

Diagnostic Test: vital signs monitoring

10:30 Measurement team

At 10:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.

Diagnostic Test: vital signs monitoring

16:30 Measurement team

At 16:30 , monitoring respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.

Diagnostic Test: vital signs monitoring

high altitude environment

In high altitude environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration

Diagnostic Test: vital signs monitoring

limited space

In limited space environments, monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration

Diagnostic Test: vital signs monitoring

electrified operation

In electrified operation , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration

Diagnostic Test: vital signs monitoring

work site

In work site , monitoringRespiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration

Diagnostic Test: vital signs monitoring

Interventions

vital signs monitoringDIAGNOSTIC_TEST

Monitoring of vital signs using portable respiratory sleep monitors, NoxT3, carbon dioxide monitors, transcutaneous oxygen and carbon dioxide partial pressure monitors

10:30 Measurement team16:30 Measurement team8:00 Measurement teamelectrified operationhigh altitude environmentlimited spacework site

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Frontline National Grid Emergency Responders

You may qualify if:

  • No history of coronary heart disease, hypertension, asthma, upper respiratory tract infection, decompression sickness, or anemia.
  • Voluntarily participated in this study and signed an informed consent form

You may not qualify if:

  • Patients with severe heart disease and arrhythmia; patients with vital organ failure; patients with significant generalized edema; patients with dermatologic disease and generalized skin breakdown; and patients with vascular disorders of the limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • luan xiaorong

    Shandong University Qilu Hospital

    STUDY CHAIR

Central Study Contacts

Ma dedong

CONTACT

18560082806ma@qiluhuxi.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 10, 2023

Study Start

October 15, 2023

Primary Completion

December 31, 2023

Study Completion

February 1, 2024

Last Updated

October 10, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)